Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation

NCT ID: NCT04013997

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-11
• Study Completion Date: 2018-06-12

Brief Summary

To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery.

Detailed Description

Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery.

The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training.

Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA.

Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity.

Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM).

Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians would identify patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants.

After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determines it is safe for participants to begin standing, and continued until the participant is discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living (functioning) compared to the matched control group who didn't have Ekso training and were chosen by a retrospective chart review.

Conditions

Spinal Cord Injuries; Inpatients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Exoskeletal-assisted walking training group

Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study.

Group Type: EXPERIMENTAL

EksoGT

Intervention Type: DEVICE

The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.

Matched control group

Twenty inpatients with SCI were identified as the matched control group through reviewing an acute inpatient rehabilitation database of Uniform Data System for Medical Rehabilitation by a person blinded to the study.

The control group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. The control groups received the same amount of acute rehabilitation time per week as the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EksoGT

The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.

Intervention Type: DEVICE

Other Intervention Names

Exoskeletal-assisted walking training

Eligibility Criteria

Inclusion Criteria

• Age 18 years or greater
• Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
• Weight less than 220 pounds (100 kilograms)
• Near Normal range of motion (ROM), as follows:
• Hip: 5 degrees of extension; 110 of flexion
• Knee: Full extension to 110 of flexion
• Ankle: at least 0 of dorsiflexion to 25 of plantarflexion
• Are eligible for locomotor training as part of inpatient rehabilitation
• Independent with static sitting balance
• Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches)
• Able to follow directions

Exclusion Criteria

• Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
• Inability to stand upright due to orthostatic hypotension
• Body characteristics that do not fit within exoskeleton limits
• Upper leg length discrepancy > 0.5" or lower leg discrepancy >0.75"
• Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
• Pregnancy
• Colostomy
• Non-English Speaking
• The participant is able to walk better with exoskeleton assistance at baseline
• Any other issue that might prevent safe standing or walking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Miguel Escalon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel X Escalon, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

The Mount Sinai Hospital

New York, New York, United States

Countries

United States

Other Identifiers

GCO 15-2253

Identifier Type: -

Identifier Source: org_study_id